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Clinical Trial Summary

This will be a randomized double blind placebo-controlled pilot study using a repeated measures design in which participants with acute ischemic stroke and upper extremity weakness are randomized to either drug or placebo


Clinical Trial Description

This will be a randomized double blind placebo-controlled pilot study using a repeated measures design in which participants with acute ischemic stroke and upper extremity weakness are randomized to either drug or placebo, complete therapy, and complete outcomes assessments at baseline, 4, and 12 weeks post-stroke. Target enrollment will be 10 patients per group and adaptive randomization will be used to assist with equal representation of pre-stroke selective serotonin reuptake inhibitor (SSRI) use and motor severity (Fugl-Meyer score) in each arm. The primary purpose of this pilot study is to measure adverse events, drop-out rates, feasibility of trial conductance, and establishment of effect sizes in each group in order to power a larger efficacy trial at the University of Utah. An intention to treat model will be used during the study. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02144584
Study type Interventional
Source University of Utah
Contact
Status Active, not recruiting
Phase Early Phase 1
Start date January 2014
Completion date May 2025

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